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Boston Scientific’s Lotus Aortic Valve Has Promise in Study

May 22 (Bloomberg) -- Boston Scientific Corp.’s Lotus
device, inserted through a catheter into the heart to fix a
damaged aortic valve, was safely implanted without any severe
leakage in a study being conducted for European approval.

The findings presented at the EuroPCR meeting in Paris
showed the Lotus device improved blood flow through the repaired
aortic valve, without complications such as the need for by-pass
surgery. One of the 60 patients developed moderate regurgitation
around the valve, which has been tied to a higher risk of death,
while 79 percent had little to no leakage. Almost 30 percent
needed a pacemaker after treatment.

The valve from Natick, Massachusetts-based Boston
Scientific would compete against devices from Medtronic Inc. and
Edwards Lifesciences Corp. if it wins European approval. It has
a feature known as the Adaptive Seal that was designed to
minimize the paravalvular regurgitation risk. It also can be
moved as physicians find the best spot to deploy the valve, or
pulled out of the heart entirely if needed to ensure the best
result. Edwards sells the only catheter-based valve in the U.S.

“This is a game-changer because all the first generation
devices aren’t repositionable when fully deployed,” said
researcher Ian Meredith, director of Monash Heart at Monash
Medical Centre in Melbourne. “There comes a point in the
procedure where you have to let the valve go. With Lotus, you
have almost obliterated the likelihood of regurgitation and at
the same time given extreme control to the operator to get the
valve positioned in exactly the right place.”

Marketing Advantage

The very low rates of leakage around the valve should help
Boston Scientific market the device, even though the number of
patients needing pacemakers was high, said Danielle Antalffy, an
analyst at Leerink Swann in New York, in a note to investors.
Getting less leakage in exchange for higher pacemaker rates than
with Edward’s Sapien XT valve is “a trade-off we suspect many
physicians will be willing to accept,” she said.

“Based on the data we saw today, we expected Boston
Scientific will be able to gain CE mark approval in Europe in
the second half of 2013 and compete primarily against Edwards
and Medtronic, who currently split the market,” she wrote.

Boston Scientific is expected to begin the studies needed
for U.S. approval of Lotus sometime next year.

Boston Scientific declined 1.1 percent to $9.13 at the
close in New York. The shares gained 54 percent in the past 12
months.